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engagement with professional groups, health service staff, voluntary organisations, patients affected by renal cancer and the wider public.

7. Quality Performance Indicators for Renal Cancer

Proportion of patients with
RCC who
undergo pre-treatment cross-sectional imaging of the chest,
abdomen +/- pelvis.

Rationale and Evidence:

Although definitive diagnosis of renal cell carcinoma
requires pathological assessment, radiology suggests the
diagnosis in almost all cases and is the first line of
investigation.

Patients with renal cell carcinoma should undergo
CT with
contrast to assess the extent of local and distant
metastatic disease
[5].
MRI
is also an alternative option for patients who require
further imaging, or have allergies to intravenous
CT contrast
media
[6].

Specifications:

Numerator:

Number of patients receiving active treatment
[1] with a diagnosis of
RCC who
undergo cross-sectional imaging (
CT or
MRI)
of the chest, abdomen +/- pelvis (with contrast) before
first treatment.

The tolerance within this target is to account for those
patients with contraindications due to renal impairment,
allergies to contrast media, and also where renal cancer is
an incidental finding following surgery.

QPI2 - Histological Diagnosis

QPI
Title:

Patients with renal cancer not undergoing surgery should
have a histological diagnosis prior to commencing
treatment.

Description:

Proportion of patients with
RCC where
surgery is not the primary treatment who have a
histological diagnosis before treatment, via biopsy.

Please note: the specifications of this
QPI are
separated to ensure clear measurement of patients
undergoing the following treatments:

(i) Cryotherapy / Radiofrequency ablation

(ii) Systemic Anti-Cancer Therapy (
SACT)

Rationale and Evidence:

With alternative minimally invasive therapies such as
radio frequency ablation (
RFA) and
cryotherapy where the primary tumour is not resected, it is
essential to make a histological or cytological diagnosis
of renal carcinoma prior to treatment to avoid treating a
non-malignant lesion
[5,7].

In patients who are being considered for expensive
medical anti-cancer therapy, histological confirmation of
the diagnosis is essential as other cell types will not
benefit from this treatment
[8].

Specification (i):

Numerator:

Number of patients with
RCC
undergoing cryotherapy or radiofrequency ablation as their
first treatment who have a histological diagnosis
(confirmed by biopsy) before commencing treatment.

Denominator:

All patients with
RCC
undergoing cryotherapy or radiofrequency ablation as their
first treatment.

Exclusions:

Histology not assessable.

Target:

90%

The tolerance within this target accounts for situations
where patients may require treatment urgently.

Specification (ii):

Numerator:

Number of patients with
RCC
undergoing
SACT as
their first treatment who have a histological diagnosis
(confirmed by biopsy) before commencing treatment.

Denominator:

All patients with
RCC
undergoing
SACT as
their first treatment.

Exclusions:

Histology not assessable.

Target:

90%

The tolerance within this target accounts for situations
where patients may require treatment urgently.

QPI3 - Clinical Staging -
TNM

QPI
Title:

The
TNM
staging system should be used to stage patients with Renal
Cell Carcinoma (
RCC).

Description:

Proportion of patients whose
RCC is
staged pre-treatment using the
TNM
staging system.

Rationale and Evidence:

The
TNM
stage of disease will aid in determining prognosis, choice
of therapy and follow up
[9].

The
TNM
staging system is widely recommended for staging of renal
cell carcinoma as it
[6,9].

Specifications:

Numerator:

Number of patients diagnosed with
RCC who
were clinically staged using
TNM
staging system before first treatment.

Denominator:

All patients diagnosed with
RCC.

Exclusions:

No exclusions

Please Note:

For a patient to be recorded as having been clinically
staged using the
TNM
staging system, cT, cN and cM
all require to be recorded.

Target:

100%

QPI 4 -
Multi-Disciplinary Team (
MDT)
Meeting

QPI
Title:

Patients with renal cell carcinoma should be discussed
by a multidisciplinary team prior to definitive
treatment.

Description:

Proportion of patients with renal cell carcinoma who are
discussed at
MDT
meeting before definitive treatment.

Rationale and Evidence:

Evidence suggests that patients with cancer managed by a
multi-disciplinary team have a better outcome. There is
also evidence that the multidisciplinary management of
patients increases their overall satisfaction with their
care
[8].

Discussion prior to definitive treatment decisions being
made provides reassurance that patients are being managed
appropriately.

Specifications:

Numerator:

Number of patients with renal cell carcinoma discussed
at the
MDT
before definitive treatment.

Denominator:

All patients with renal cell carcinoma.

Exclusions:

Patients who died before first treatment.

Target:

95%

The tolerance within this target is designed to account
for situations where patients require treatment urgently or
where renal cancer has been an incidental finding following
surgery.

When compared with radical nephrectomy,
NSS can
achieve preserved renal function, decreased overall
mortality, reduced frequency of cardiovascular events and
increased quality of life for patients. Patients should be
informed of these potential advantages of nephron sparing
surgery
[5].

Surgical resection is the gold standard of care for
curative treatment of
RCC.
Patients with T1a tumours should undergo nephron sparing
surgery where appropriate, as clinical trials have shown
that long term survival rates are comparable to those
following radical surgery
[5,7,9].

This target reflects the fact that some patients opt for
a laparoscopic radical nephrectomy (
LRN)
rather than nephron sparing surgery (
NSS) due
to factors such as shorter convalescence period and
decreased complications associated with
LRN
compared to
NSS.

Including this patient group in the exclusion criteria
noted above would by default make the target meaningless as
100% would be achieved.

Proportion of patients with clear cell
RCC who are
assigned a Leibovich score following surgical
resection.

Rationale and Evidence:

Various prognostic scores exist to predict the
likelihood of developing metastatic disease following
surgery.

Evidence shows that the Leibovich score is an accurate
model of prediction and assists clinicians and patients in
making decisions regarding treatment plans, follow up and
selection for clinical trials
[10].

Specifications:

Numerator:

Number of patients with clear cell
RCC who
undergo surgical resection assigned a Leibovich score
following surgical resection.

Denominator:

All patients with clear cell
RCC who
undergo surgical resection.

Exclusions:

Patients undergoing partial nephrectomy

Patients with metastatic disease (TanyNanyM1)

Target:

100%

QPI 7 -
Volume of Cases per Centre / Surgeon

QPI
Title:

Renal resectional surgery should be performed in
hospitals where there are an appropriate annual volume of
such cases.

Description:

Number of renal surgical resections performed by a
specialist centre, and surgeon, over a 1 year period.

Rationale and Evidence:

A number of studies have demonstrated the relationship
between the number of patients operated on at a particular
hospital and the outcome of surgery.

The literature demonstrates that there is a relationship
between increasing surgical volume and lower complication
rates for surgeons undertaking partial nephrectomy for
renal cell carcinoma
[11].

Specifications:

Number of renal surgical resections performed by each
centre / surgeon in a given year.

Exclusions:

No exclusions

Target:

Minimum 25 procedures per centre, with a minimum of 8
procedures per surgeon, in a 1 year period.

This is a minimum target level and is designed to ensure
that all surgeons performing renal surgery perform a
minimum of 8 procedures per year.

Please Note: Varying evidence exists
regarding the most appropriate target level for surgical
case volume. In order to ensure that the target level takes
account of level 1 evidence and will drive continuous
quality improvement as intended this performance indicator
must be kept under regular review.

Please note:

SMR01 data
will be utilised to support reporting and monitoring of this
QPI rather
than clinical audit. This will maximise the use of data which are
already collected and remove the need for any duplication of data
collection. Standard reports are currently being specified and
direct access for each Board to run these reports is being
investigated to ensure nationally consistent analysis and
reporting.

*Length of stay is being used as a surrogate measure for
the quality of surgery and post operative care including
post operative complications.

Specifications:

Numerator:

Number of patients with T1a
RCC
undergoing partial nephrectomy who have warm ischaemic time
less than 25 minutes, negative surgical margins and no
complications (length of stay ≤7days).

Denominator:

All patients with T1A
RCC
undergoing partial nephrectomy.

Exclusions:

No exclusions

Target:

60%

The tolerance within this target takes account of the
fact that it is not always possible to achieve trifecta due
to patient fitness, complex lesions and in solitary
kidneys. It may also not always be safe or practical for
patients to go home within 7 days of surgery.

QPI
9-30 / 90 Day Mortality

QPI
Title:

30 and 90 Day Mortality following treatment for
RCC.

Description:

Proportion of patients who die within 30 or 90 days of
treatment for
RCC.

Rationale and Evidence:

Treatment related mortality is a marker of the quality
and safety of the whole service provided by the Multi
Disciplinary Team (
MDT).
However, all causes of death have been used in this
indicator as the recording of cause of death by the
certifying medical practitioner is not always as specific
as the recording of a cancer diagnosis.

"For clinicians to restore and retain public confidence,
they need to show that effective mechanisms exist for
assessing events such as death and to justify patients'
faith in the delivery of care"
[13].

Specifications:

Numerator:

Number of patients with
RCC who
undergo minimally invasive (
RFA,
cryotherapy,
SACT) or
operative treatment who die within 30 / 90 days of
treatment.

Proportion of patients with metastatic
RCC who are
assigned a valid prognostic score
[2] prior to starting treatment.

Rationale and Evidence:

Various models exist to predict the survival and
prognosis for patients with metastatic
RCC. These
are key in making decisions about the most appropriate
treatment plan for patients, particularly with the use of
targeted therapies
[14].

Specifications:

Numerator:

Number of patients with metastatic
RCC who are
assigned a valid prognostic score prior to starting
treatment.

Denominator:

All patients diagnosed with metastatic
RCC.

Exclusions:

No exclusions

Target:

90%

The tolerance within this target is to account for
situations where patients are deemed unfit to undergo
active treatment.

Sunitinib is currently recommended for use in Scotland
as a first-line treatment option for people with advanced
and/or metastatic
RCC who are
suitable for immunotherapy and have an Eastern Cooperative
Oncology Group (
ECOG)
performance status of 0 or 1
[15]. Pazopanib is recommended by the Scottish Medicines
Consortium (
SMC) as a
first line treatment option for people with advanced
RCC[16,17] Although the
SMC advice
does not restrict patients according to
ECOG
performance status, the clinical trial supporting its use
was restricted to
ECOGPS 0 or 1
patients.

Large randomised clinical trials have demonstrated
clinical effectiveness of a variety of agents in this
setting. Cost effectiveness analysis has demonstrated that
sunitinib and pazopanib are considered cost effective in
this setting within
NHS
Scotland.

In some cases it is reasonable to delay systemic therapy
and the assumption is that 100% of suitable patients should
receive systemic therapy between diagnosis and death. We
estimate that at least 40% of these patients would be
expected to die within 12 months of diagnosis in the
absence of systemic treatment and therefore have chosen
this time period as suitable for assessing this aspect of
practice.

Specifications:

Numerator:

Number of patients with
RCC which
is advanced and / or metastatic at time of diagnosis
[3] treatment with SACT, within 12 months of diagnosis
where at least 12 months have elapsed since diagnosis
irrespective of whether or not they have died who receive
first treatment with
SACT, within
12 months of diagnosis
[4].

Denominator:

All patients with
RCC which
is advanced and / or metastatic at time of diagnosis where
at least 12 months have elapsed since diagnosis
irrespective of whether or not they have died.

Exclusions:

Patients documented to have performance status 2, 3
or 4 at time of diagnosis.

The target reflects the following facts: i. some
patients will decline very quickly and systemic therapy is
inappropriate; ii. some will have very indolent disease and
systemic therapy is not appropriate within 12 months of
diagnosis; iii. some patients will die of unrelated causes
within 12 months of diagnosis without the need for systemic
anti-cancer therapy; iv. some patients will have specific
medical contra-indications to systemic therapy; v. some
patients with isolated metastatic disease may undergo
surgical resection.